FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2191979
·
Received August 4, 2011
Report
- Report Number
- 3006630150-2011-01158
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- July 18, 2011
- Report Date
- July 18, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2218-50, (B)(4), MODEL DESCRIPTION:ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET MODEL#:SC-3138-55, (B)(4) MODEL DESCRIPTION:LEAD EXTENSION, 55CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD BE EXPLANTED AS HER ARM WOULD SHAKE UNCONTROLLABLY WHILE THE STIMULATION WAS TURNED ON.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD BE EXPLANTED AS HER ARM WOULD SHAKE UNCONTROLLABLY WHILE THE STIMULATION WAS TURNED ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |